Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder (TINA)

February 12, 2026 updated by: Apsen Farmaceutica S.A.

Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

222

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil, 12916-900
        • UNIFAG - Casa Nossa Senhora da PAZ -ASF
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants aged between 18 and 64 years;
  • Participants diagnosed with insomnia disorder according to the criteria defined by the DSM-V (1) and who report sleep maintenance disorder;
  • Participants who agree not to use alcoholic beverages during the entire treatment period (6 weeks).

Exclusion Criteria:

  • Participants with known hypersensitivity to the active ingredients used during the trial or who have exhibited complex sleep behavior after using them;
  • Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
  • Women who are pregnant or breastfeeding, as well as women who have a positive result on a pregnancy test (β-hCG) during the screening period of the trial;
  • Participants diagnosed with severe liver failure;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APSTZD 1
5 oral tablets, once a day, before bedtime, for 6 weeks.
Drug: APSTZD 1
APSTZD + placebo test 2 + placebo test 3 + placebo test 4 + comparator placebo 1
Experimental: APSTZD 2
5 oral tablets, once a day, before bedtime, for 6 weeks.
Drug: APSTZD 2
APSTZD + placebo test 1 + placebo test 3 + placebo test 4 + comparator placebo 1
Experimental: APSTZD 3
5 oral tablets, once a day, before bedtime, for 6 weeks.
Drug: APSTZD 3
APSTZD + placebo test 1 + placebo test 2 + placebo test 4 + comparator placebo 1
Experimental: APSTZD 4
5 oral tablets, once a day, before bedtime, for 6 weeks.
Drug: APSTZD 4
APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1
Active Comparator: Stilnox CR®
5 oral tablets, once a day, before bedtime, for 6 weeks.
Drug: Stilnox CR®
Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4
Placebo Comparator: Placebo
5 oral tablets, once a day, before bedtime, for 6 weeks.
Drug: Placebo
placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography
Time Frame: Change from baseline after 2 weeks of treatment
Change from baseline after 2 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events incidence and classification
Time Frame: Through study completion, up to 6 weeks
Through study completion, up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apsen Farmaceutica S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 26, 2026

Primary Completion (Estimated)

September 23, 2027

Study Completion (Estimated)

September 23, 2027

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APS002/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia

Clinical Trials on APSTZD 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe